NCT06106217

Brief Summary

Geriatric problems develop with aging in individuals over 60 years of age. These problems include muscle weakness, balance disorders and changes in quality of life. The aim of our study is to examine the effects of BAPNE (BMe) and qi gong (QG) exercises on balance and quality of life in individuals over the age of 60. In this study, parameters such as fall risk, muscle testing, balance, functional capacity, cognitive functions, depression and sleep quality were evaluated. 56 participants were included in the study. All cases were evaluated for the first time before they were included in the study. In the initial evaluation, Itaki fall risk questionnaire, 6-minute walk test, Berg balance scale, Pittsburg sleep quality index, World Health Organization quality of life scale elderly module, Beck depression scale, mini mental state test, object flipping test, word fluency test, stroop test, muscle strength with Jtech brand myometer and balance on Libra balance board were measured. Participants were divided into groups of 2-6 people, and second assessments were made after a total of 20 sessions of BMe exercises for 6 weeks. After a 2-week rest period, the participants were included in the third assessment and included a total of 20 sessions of QG exercise over 6 weeks. At the end of 6 weeks, the fourth evaluation was made.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

October 12, 2023

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Ithaki Fall Risk Questionnaire

    This developed scale consists of a total of 19 risk factors, including risk factors that may cause patient falls. Risk factors were categorized as major and minor, and minor risk factors were given 1 point and major risk factors were given 5 points. Two risk levels, low and high, were determined over the total score obtained as a result of the evaluation of risk factors. In order to distinguish high-risk patients and to take necessary precautions, it is envisaged to use the "Four Leaf Clover" figure in patients at high risk of falling.

    14 weeks

  • Berg Balance Scale

    Berg balance scale is a valid, reliable and sensitive measurement method that measures functional balance. The test, which includes 14 functional tests and is completed in an average of 10-20 minutes, has a score between 0-4. At 0, the loss of balance is maximum, while at a value of 4, the patient is independent of balance. The maximum score of the test is 56, and the minimum score is 0. A high score indicates good functional balance.

    14 weeks

  • Libra Balance Board

    Balance board produced by Easytech is a computer aided balance measuring device. This device measures 42x9x42 cm and weighs 2.7 kilograms. It gives a score out of 100, 0 points the best balance and 100 points the worst balance.

    14 weeks

  • Pittsburgh Sleep Quality Index

    Buysse et al. It is a scale that defines good and bad sleep, developed by in 1989. A total of 24 questions, 19 of which are self-assessed, and 5 are answered by a roommate or spouse. These assess sleep duration, latency, and the frequency and severity of specific sleep-related problems. Evaluated with points between 0-3.

    14 weeks

  • WHOQOL-old

    It consists of 24 questions translated into Turkish as the World Health Organization quality of life module for the elderly. Validity reliability Eser S. et al. module made by; autonomy, past present and future activities, social inheritance, death-death and intimacy.

    14 weeks

Secondary Outcomes (8)

  • Demographic information

    Baseline (only in the first evaluation)

  • Muscle Strength Rating

    14 weeks

  • 6 Minute Walk Test

    14 weeks

  • Beck Depression Scale

    14 weeks

  • Mini Mental Test

    14 weeks

  • +3 more secondary outcomes

Study Arms (2)

bapne

EXPERIMENTAL
Other: bapne

qi gong

EXPERIMENTAL
Other: qi gong

Interventions

bapneOTHER

An exercise program was created in the form of a movement sequence consisting of nine movement combinations.

bapne
qi gongOTHER

The exercise program, which was prepared in a 40-minute sequence, was arranged as 10 minutes of warm-up, 20 minutes of Qi Gong exercises, and 10 minutes of cool-down.

qi gong

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be 60 years old or older
  • Able to walk independently
  • Volunteering to exercise at least 3 days a week within the scope of the research

You may not qualify if:

  • Having an orthopedic or surgical problem that prevents walking or exercising
  • Having any neurological problems
  • The presence of a pulmonary, cardiac, or systemic disease that would constitute a contraindication for exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

  • Hachenberger J, Li YM, Lemola S. Physical activity, sleep and affective wellbeing on the following day: An experience sampling study. J Sleep Res. 2023 Apr;32(2):e13723. doi: 10.1111/jsr.13723. Epub 2022 Sep 18.

    PMID: 36116773BACKGROUND
  • Zhang H, Yin L, Peng Y, Zhang G, Chen Q, Liang J, Tian S, Tong T, Liu R, Lv C, Zhao L, Liang T, Wang J, Fan L. Effect of five-elements music therapy combined with Baduanjin qigong on patients with mild COVID-19. Hong Kong J Occup Ther. 2023 Jun;36(1):31-38. doi: 10.1177/15691861231167536. Epub 2023 Apr 12.

    PMID: 37332295BACKGROUND
  • Emek Savas DD, Yerlikaya D, G Yener G, Oktem Tanor O. Validity, Reliability and Normative Data of the Stroop Test Capa Version. Turk Psikiyatri Derg. 2020 Spring;31(1):9-21. doi: 10.5080/u23549. English, Turkish.

    PMID: 32594475BACKGROUND
  • Figueira HA, Figueira OA, Figueira AA, Figueira JA, Polo-Ledesma RE, Lyra da Silva CR, Dantas EHM. Impact of Physical Activity on Anxiety, Depression, Stress and Quality of Life of the Older People in Brazil. Int J Environ Res Public Health. 2023 Jan 8;20(2):1127. doi: 10.3390/ijerph20021127.

    PMID: 36673880BACKGROUND
  • Kim SG, Lim DH, Cho YH. Analysis of the reliability of the make test in young adults by using a hand-held dynamometer. J Phys Ther Sci. 2016 Aug;28(8):2238-40. doi: 10.1589/jpts.28.2238. Epub 2016 Aug 31.

    PMID: 27630404BACKGROUND
  • Fu H, Wang L, Zhang W, Lu J, Yang M. Diagnostic test accuracy of ultrasound for sarcopenia diagnosis: A systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2023 Feb;14(1):57-70. doi: 10.1002/jcsm.13149. Epub 2022 Dec 13.

    PMID: 36513380BACKGROUND
  • Terrés JMP, Naranjo FJR, Martimez AC, Colomino NC. Perceptions towards wellness and life quality through body percussion BAPNE Method and cognitive stimulation in elderly people. Procedia - Social and Behavioral Sciences 152,1108 - 1113, 2014.

    BACKGROUND

MeSH Terms

Interventions

Qigong

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physioyherapist

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 30, 2023

Study Start

July 1, 2023

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations